Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a guideline study (OECD 406) conducted in guinea pigs using the footpad method, the subject chemical at 1% in Freund's adjuvant did not produce a skin sensitization reaction. In a second guideline study in guinea pigs following the Buehler method, the subject chemical undiluted failed to produce a skin sensitization reaction.

Migrated from Short description of key information:
Skin sensitization studies in guinea pigs following both the footpad and Buehler methods indicate the subject chemical is not a skin sensitizing agent.

Justification for classification or non-classification

The subject chemical would not be considered a skin sensitizer under the EU DSD classification criteria (EU Directive 67/548/EEC) or under the EU CLP (EU Regulation 1272/2008) or UN GHS criteria.